Citing death risk, FDA adds most severe warning to Pfizer's Tygacil

http://www.nbcnews.com/health/citing-death-risk-fda-adds-most-severe-warning-pfizers-tygacil-8C11281667

Sep. 27, 2013

Regulators are putting their harshest warning on Pfizer's antibiotic Tygacil, saying the drug is associated with an increased risk of death.

The Food and Drug Administration said Friday Tygacil, or tigecycline, should only be used in situations when other treatments aren't suitable. The intravenous drug is approved as a treatment for complicated skin and skin structure infections and community-acquired bacterial pneumonia. The FDA will add a boxed warning to the drug label, its most serious type of warning.

In 2010 the FDA said Tygacil was associated with a greater risk of death than other antibacterial drugs. It says a new analysis confirmed that conclusion. The risk was greatest in patients with ventilator-associated pneumonia. Tygacil hasn't been approved for that condition.

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